Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00542880
First received: October 10, 2007
Last updated: July 27, 2012
Last verified: July 2012

October 10, 2007
July 27, 2012
September 2007
August 2008   (final data collection date for primary outcome measure)
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.
The primary outcome is peak expiratory flow 5 minutes after morning dose.
Complete list of historical versions of study NCT00542880 on ClinicalTrials.gov Archive Site
  • PEF Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • PEF 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • PEF Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • FEV1 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • FEV1 Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
  • Change in PEF From Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.
  • Change in PEF From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
  • Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
  • Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
  • Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
  • Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ] [ Designated as safety issue: No ]
    The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
  • Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: Yes ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
  • Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
  • The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ] [ Designated as safety issue: No ]
    The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.
Secondary outcome variables will be PEF measured before & 15 min. after morning dose,& before evening dose. Patient-reported outcomes b/w visits by Morning Activities & Symptoms Questionnaires (MASQ), Clinical COPD Questionnaire (CCQ) & us
Not Provided
Not Provided
 
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
  • Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
  • Experimental: Symbicort Turbuhaler First, then Seretide Diskus
    Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
    Interventions:
    • Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
    • Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
  • Experimental: Seretide Diskus First, then Symbicort Turbuhaler
    Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
    Interventions:
    • Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
    • Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Partridge MR, Miravitlles M, Ståhl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. Epub 2009 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
  • FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
  • Pre-bronchodilator

Exclusion Criteria:

  • Current respiratory tract disorder other than COPD
  • History of asthma or rhinitis
  • Significant or unstable cardiovascular disorder
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Denmark,   Germany,   India,   Philippines,   United Kingdom
 
NCT00542880
D5892C00016
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Martyn R Partridge, MD FRCP Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP